Quidel Corp., of San Diego, has scored another win at the U.S. FDA, receiving emergency use authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay to allow direct sample processing. What’s special about this assay is that it does not require an up-front sample extraction. Instead, it uses a reformulated buffer that replaces that process with a simple 10-minute heat step, saving about 50 minutes in processing time. Read More
Waltham, Mass.-based Thermedical Inc. has received a breakthrough device designation from the U.S. FDA for its saline enhanced radiofrequency (SERF) ablation system and Durablate catheter in the treatment of ventricular tachycardia (VT). The system uses a new means of biological heat to precisely deliver ablation therapy to the heart. Read More
Deep Lens Inc. has integrated molecular data parsing and management technology into its Viper clinical trial screening and enrollment platform, enabling automated matching of patients with eligible genetic profiles to clinical trials. The Columbus, Ohio-based company licensed the proprietary technology from the University of Miami. Read More
LONDON – Heart disease is now known to be both a cause and an effect of serious COVID-19 infection, with more than 1 in 10 patients who have underlying cardiac conditions being killed by the virus, while others with no previous record of cardiovascular problems are suffering significant COVID-19 induced weakening of their hearts. Read More
Two judges with the U.S. Court of Appeals for the Federal Circuit sided with the Patent Trial and Appeal Board (PTAB) in a patent dispute between Oticon Medical and Cochlear, but the third judge, Pauline Newman took issue with the decision. Newman said the majority applied “an improper analytical technique” to determine that the preamble to a patent does not limit the related claims, despite that prior art cited to dispute the patent had been “disavowed by the preamble.” Read More
The challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. In our series “Diagnosing the state of COVID-19 testing,” BioWorld MedTechexplores the complexities of developing accurate, properly regulated tests to help bring the world back online with confidence.
New hires and promotions in the med-tech industry, including: Biolife Solutions, Cambridge Healthcare Research, Electromed, Siren, Spectral MD. Read More
Med-tech firms raising money in public or private financings, including: Alcon, Atia Vision, Boston Scientific, Cathvision, Chromacode, Medx Health. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abiomed, Axonics, Castle Biosciences, Cerapedics, Eyenuk, Limflow, Medasense. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Archerdx, Bio-Rad, Cochlear, Invivoscribe, Ortho, Quidel, Theradiag, Thermedical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Athos KT, Blue Flame Medical, Glaxosmithkline, Harsco, Lymol Medical, Pfizer, Stericycle, Vir Biotechnology. Read More
Keeping you up to date on recent developments in oncology, including: New LAT1 inhibitor may improve outcomes in cancer as part of combo therapy; Subdividing and conquering PDAC; Cell competition links hyperinsulinemia to cancer; Protons show well in study against alternatives. Read More
